Alzheimer Disease Ethics—Informed Consent and Related Issues in Clinical Trials: Results of a Survey Among the Members of the Research Ethics Committees in Sweden

Abstract

The rapid advances in biomedical sciences have induced special moral and ethical attitudes, which ought to be taken into account. One of the most essential issues is the principles for participation in research of subjects with reduced decision-making capacity.We conducted a questionnaire survey among members of the research ethics committees in Sweden to find out their attitudes to a range of ethical issues related to research on subjects with Alzheimer's disease. One hundred thirty-six of those approached responded (66%), and 117 of the responses (56%) were considered substantially complete. There were 16 questions with fixed reply alternatives. Some central questions concerned the informed consent process. With a few exceptions, there were no significant differences in attitudes between the experts and laypersons, between persons of different ages, and between men and women. However, women and laypersons were in general keener to preserve the patient's integrity and the experts were more willing than the laypersons to allow participation of subjects with dementia in placebo-controlled trials.

Comfort with proxy consent to research involving decisionally impaired older adults: do type of proxy and risk-benefit profile matter?

“…Although they elicited opinions differently by presenting hypothetical or actual studies, these studies also concluded that a large number of older adults (Wendler et al ., 2002; Ayalon, 2009; Karlawish et al ., 2009; Kim et al ., 2009a) and informal caregivers of persons with dementia (Karlawish et al ., 2008; Kim et al ., 2010) support proxy consent from a family member. Research Ethics Committee members are largely in favor of proxy consent to research from a family member if there is “potential therapeutic benefit for the subject and no more than minimal risk for adverse events” (Peterson and Wallin, 2003). The proportion in favor of proxy consent however drops substantially if there is “no potential therapeutic benefit for the subject with no more than minimal risk for adverse events but potential therapeutic benefit to others”.…”

Decisions and attitudes regarding participation and proxy in clinical trials among patients with impaired cognitive function

“…A debated issue in dementia research concerns obtaining informed consent from patients with impaired cognitive function (e.g. Peterson and Wallin, 2003;Slaughter, Cole, Jennings, & Reimer, 2007). Critical ethical issues associated with medical decision-making concern for example patient autonomy.…”

End of Life Care: Attitudes Toward Autonomy and Legal Instruments

“…An inquiry in Sweden demonstrated that women and laypersons were generally keener to preserve a patient's integrity and medical professionals were more willing than laypersons to permit individuals with dementia to participate in placebo-controlled trials (Peterson &Wallin 2003). Confidentiality in research is critically important, but it is not an absolute legal principle in either research or clinical settings (Stiles & Petrila, 2011).…”